# FDA 483 - Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center - January 11, 2023

Source: https://www.keypedia.com/records/483/regents-of-the-university-of-california-on-behalf-of-ucla-fertility-and-reproductive-health-center/5206a5e8-80e1-4239-b594-b9623ca7bd8d

> FDA 483 for Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center on January 11, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center
- Inspection Date: 2023-01-11
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center in Los Angeles, CA, and identified significant deficiencies in their donor screening and eligibility determination processes. The facility failed to adequately screen oocyte and semen donors for Zika virus and did not establish proper procedures for donor eligibility. Additionally, donors were deemed eligible prior to the review of all relevant communicable disease testing records.

## Related Officers

- [Celeta S. Coves](https://www.keypedia.com/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.keypedia.com/companies/regents-of-the-university-of-california-on-behalf-of-ucla-fertility-and-reproductive-health-center/ec1360c3-8609-4a0e-ad8a-ec59af5965d3

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6